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The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in:

-Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
-Treatment of wrinkles, rhytides, furrows, fine lines;
-Pigmented lesions;
-Textural irregularities;
-Vascular dyschromia.

The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of:

• Actinic and seborrheic keratoses;
  -Chelitis;
  -Cutaneous horns;
  -Hemangiomas;
  -Keloids;
  -Nevi, including spider, epidermal and protruding;
  -Rhinophyma;
  -Syringomas;
  -Warts;
  -Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.

The Fraxel re:pair Laser System consists of a CO2 laser source and three delivery handpieces for resurfacing, incision and debulking procedures. Each handpiece attaches to an articulating arm. Additional device accessories include interchangeable resurfacing treatment tips, incisional handpiece spatulas, and debulking handpiece spatulas.

The provided text is a 510(k) summary for the Fraxel re:pair (Fraxel III SR) Laser System and Accessories. It focuses on establishing substantial equivalence to previously marketed devices (K063038, K071051, K022060, K030147) rather than presenting a study with specific acceptance criteria and detailed performance metrics for this particular device.

Therefore, the information required to populate the tables and answer the questions regarding acceptance criteria and a study proving the device meets those criteria is largely not present in the provided document. The document describes clinical performance data from "Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece," but it does not provide details of these studies, such as specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

It states: "Substantial equivalence for the Fraxel re:pair Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications for use statements and equivalent performance specifications." This indicates that the device's clearance is based on its similarity to existing cleared devices, not on a new, independent study with defined acceptance criteria for this specific iteration.

However, I will extract any relevant information that might vaguely touch upon the requested points, even if it doesn't fully fulfill the criteria.

Acceptance Criteria and Reported Device Performance

As noted, the document does not define specific, quantifiable acceptance criteria or provide a table of performance metrics for this new device's clinical performance. The substantial equivalence argument relies on the predicate devices having "equivalent performance specifications."

Study Information (Based on available text)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified in the provided document.
   • Data Provenance: Not specified in the provided document. The document mentions "Non-Significant Risk and Investigational Device Exemption studies," suggesting prospective clinical studies, but no details are given.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not specified in the provided document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not specified in the provided document.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable/Not mentioned. This is a medical device (laser system) for dermatological procedures, not an AI-assisted diagnostic device typically subject to MRMC studies comparing human reader performance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable/Not mentioned. This is a laser system, not an AI algorithm. Its performance is inherent to the device's physical operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not specified in the provided document. For clinical studies supporting laser systems, ground truth often involves clinical assessments, photographic documentation, and patient-reported outcomes related to the treated conditions (wrinkles, lesions, etc.).

7. The sample size for the training set

   • Not applicable/Not mentioned. This is a hardware medical device, not an AI model that requires a training set in the conventional sense.

8. How the ground truth for the training set was established

   • Not applicable/Not mentioned.

Summary of what is available in the document regarding studies:

The document briefly states: "Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece." This confirms that clinical studies were performed, but the 510(k) summary itself does not provide the detailed study results, acceptance criteria, methodologies, or sample sizes of these studies. The substantial equivalence argument relies on the existence of these studies for the predicate device, or implicitly, for this device's performance being similar to the predicates.

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The Fraxel III SR Laser System and accessories is intended for use in:

Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.

Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.

This 510(k) summary describes a Fraxel III SR Laser System (Fraxel re:pair™) for dermatological procedures. It doesn't contain information about a study with acceptance criteria and a reported device performance table as would be typical for an AI/ML device submission. Instead, it relies on substantial equivalence to predicate devices and clinical data from non-significant risk and investigational device exemption studies to support its safety and effectiveness.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. This submission is for a medical device (laser system), not an AI/ML diagnostic or predictive tool, and thus the structure of its performance evaluation is different. Performance is asserted based on clinical intent and no new safety/effectiveness issues, rather than statistical metrics against specific acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not explicitly provided. The document states:
"Non-Significant Risk and Investigational Device Exemption studies support the clinical performance of the Fraxel III SR (Fraxel re:pair) Laser System."
"Sufficient clinical data supported the determination of safety and effectiveness for the Fraxel III SR (Fraxel re:pair) Laser System and Accessories."

Without access to the actual study reports, details on sample sizes, patient demographics, data provenance (e.g., country of origin, retrospective/prospective nature), or specific evaluation methodologies for these underlying clinical studies are unavailable in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. The assessment relies on the overall clinical performance demonstrated in the aforementioned studies, but the role of experts for "ground truth" as you'd define it for an AI model is not detailed here. The clinical evaluation implicitly involves medical professionals, but their specific role in establishing "ground truth" for a test set is not described.

4. Adjudication Method for the Test Set

This information is not provided. As this is not an AI/ML submission where a ground truth is established for a test set through human review, an adjudication method for such a test set is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A MRMC comparative effectiveness study is not mentioned. This type of study is more relevant for AI/ML diagnostic tools where the impact of AI assistance on human readers is being evaluated. This submission is for a therapeutic laser device.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

A standalone performance study is not applicable and therefore not mentioned. This device is a laser system; its "performance" is inherently tied to its application by a trained medical professional. It does not operate as an algorithm independently.

7. The Type of Ground Truth Used

The concept of "ground truth" as applied to AI/ML models is not directly applicable or discussed in this document. The "ground truth" for a therapeutic device's effectiveness would be clinical outcomes observed in patients (e.g., reduction in wrinkles, successful soft tissue ablation), as determined by medical professionals in the clinical studies. The summary states that "The device performed as clinically intended with no new issues of safety and effectiveness introduced."

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" in the context of machine learning is not relevant to this submission, which is for a hardware device (laser system). The "training" here would refer to the engineering and development of the laser itself and clinical trials involving patients.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. Again, the concept of "ground truth for a training set" as used for AI/ML models is not directly applicable to a therapeutic laser device. The "ground truth" in device development relates to engineering specifications and clinical efficacy/safety observed in product development and clinical trials.

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The Fraxel III SR Laser System and accessories is intended for use in:

Dermatological procedures requiring ablation (removal), coagulation and resurfacing of soft tissue.

The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.

The provided text describes the 510(k) summary for the Fraxel III SR Laser System. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a detailed study.

The document states:

• "Clinical analysis was conducted on Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel III SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel III Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced."

This indicates that clinical studies were performed, and favorable safety data was collected, but the specific metrics, acceptance criteria, sample sizes, expert details, or study methodology (e.g., MRMC, standalone) are not provided in this summary.

Therefore, I cannot fill out the detailed tables and information sections you requested based solely on the provided text. The document focuses on regulatory approval based on "substantial equivalence" to predicate devices rather than a detailed report of a specific clinical trial's performance metrics against predefined acceptance criteria.

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